CanWell Pharma’s First-in-Class innovative drug CAN2109 granted IND approval by China National Medical Products Administration (NMPA)

CanWell Pharma announced that its First-in-Class innovative drug CAN2109, has been granted IND approval by the China National Medical Products Administration (NMPA).  CanWell plans to immediately initiate the patient enrollment to evaluate CAN2109’s safety, PK, PD and clinical activity for the treatment of various solid tumors.

CAN2109 is a novel long-acting Immunogenic cell death (ICD) inducer, which acts as a bi-functional immune modulator to kill tumor cells while preserving tumor antigens for efficient cross-priming of tumor-specific T cells.  CAN2109 not only possesses direct tumor cell killings, but also induces strong cell-mediated immune responses including both CD4+ and CD8+ T cells activation. In addition, CAN2109 synergizes with checkpoint inhibitors to induce systemic immunity with regression of local and distant tumors.

CanWell’s CAN2109 IND Granted Approval by US FDA

CanWell Pharma announced that its First-in-Class innovative drug CAN2109, has been granted clinical approval by the US Food and Drug Administration (FDA) and it will soon conduct Phase I clinical trial for various solid tumors.

CAN2109 is a novel long-acting Immunogenic cell death (ICD) inducer, which acts as a bi-functional immune modulator to kill tumor cells while preserving tumor antigens for efficient cross-priming of tumor-specific T cells.  CAN2109 not only possesses direct tumor cell killings, but also induces strong cell-mediated immune responses including both CD4+ and CD8+ T cells activation. In addition, CAN2109 synergizes with checkpoint inhibitors to induce systemic immunity with regression of local and distant tumors.

Canwell to Present CAN1012 Research Update at the 4th STING & TLR Targeting Therapies Summit

CanWell announced today that the preclinical research results and clinical plan of the company’s TLR7 agonist CAN1012 would be presented at the 4th STING & TLR Targeted Therapy Summit in 2023.

CAN1012 is a highly selective small-molecule TLR7 agonist developed by CanWell with global intellectual property rights. Preclinical studies have shown that it has high selectivity and potency, with low toxicities. It can exert sustained stimulation of the target cells in the tumor microenvironment, transforming “cold” tumors with low immune response into “hot” tumors with augmented immune response, playing a crucial bridging role in the innate and adaptive immune systems. In addition, it may be administered in combination with various drugs such as immunotherapy checkpoint inhibitors, as well as radiotherapy and chemotherapy, to produce highly synergistic effects.

The CAN1012 Phase I clinical trial is an open-label, multicenter, dose-escalation, and dose-expansion study aimed at evaluating the safety, tolerability, and preliminary efficacy of the drug in late-stage solid tumor patients as a single agent, and determining the maximum tolerated dose and recommended Phase II dose. Currently, the study is being conducted simultaneously in China and the United States.

The 4th STING & TLR Targeted Therapy Summit brought together more than 100 industry-leading immune targeted therapy organizations from the large biopharmaceutical industry and academic institutions. The event provides a unique opportunity to present and share the latest development and progress in the field of STING and TLR agonist based therapeutics.

CanWell was Invited to Present at 9th Immuno-oncology 360° (IO360°) Conference

CanWell presented the preclinical research results of CAN1012, a small molecule TLR7 agonist in the form of an oral presentation at the 9th Immuno-oncology 360° (IO360°) conference.

The IO360° conference is a globally renowned annual conference for cancer immunotherapy, providing a collaboration opportunity for pharmaceutical/biotech companies, academia, and investors. The conference offers the platform where the latest progresses of cancer immunotherapy are shared and exchanged.

CanWell presented the preclinical research results of CAN1012 at the annual meeting of the Society for Immunotherapy of Tumors (SITC)

CanWell announced today that the preclinical results of its small molecule TLR7 agonist CAN1012 were presented at the 37th Annual Meeting of the Society for Immunotherapy of Tumors (SITC 2022, Boston).

Abstract ID: #1171

Poster title: CAN1012: A SELECTIVE AND POTENT TLR7 AGONIST WITH STRONG ANTITUMORAL PROPERTIES MEDIATED BY LOCALIZED INNATE IMMUNE ACTIVATION

Time: November 8-12, 2022. Boston US

CAN1012 is a slow-release selective TLR7 receptor agonist exclusively developed by CanWell with global intellectual property rights. Preclinical studies have shown that CAN1012 has high selectivity and activities with low toxicities.  It continuously stimulates the target immune cells in the tumor microenvironment, releasing a variety of cytokines/chemokines related to drug efficacy, thereby promoting the activation of anti-tumor immune cells and their infiltration into the tumor, transforming the “cold” tumor with a low immune response into a “hot” tumor with a strong immune response. When CAN1012 is used as a single agent in various preclinical tumor models, it has shown robust anti-tumor activities, while exhibiting extremely low systemic exposure. In addition, CAN1012 can be combined with a variety of tumor immune checkpoint inhibitors, targeted therapy drugs or chemotherapy to produce stronger anti-tumor activities.

CAN1012 is currently in clinical Ph I development  in China and the United States. In June 2021, it obtained IND approval from the US FDA and entered phase I clinical trial (NCT04987112) in the US. In July 2022, it received IND clearance from the Chinese CDE (JXHL2200119). A multi-center phase I clinical trial is currently ongoing in China.

First patient dosed in CanWell’s CAN1012 Ph1 Trial in China

CanWell Biotech Ltd. , a company specializing in the development of innovative immune-oncology drugs, announced today that the 1st patient has been successfully dosed in its ongoing CAN1012 Ph1 clinical trial in China.

The CAN1012 Phase I clinical trial is an open-label, multicenter, dose-escalation, and dose-expansion study aimed at evaluating the safety, tolerability, and preliminary efficacy of the drug in late-stage solid tumor patients as a single agent, and determining the maximum tolerated dose and recommended Phase II dose. Currently, the study is being conducted simultaneously in China and the United States.

CAN1012 is a highly selective small-molecule TLR7 agonist developed by CanWell with global intellectual property rights. Preclinical studies have shown that it has high selectivity and potency, with low toxicities. It can exert sustained stimulation of the target cells in the tumor microenvironment, transforming “cold” tumors with low immune response into “hot” tumors with augmented immune response, playing a crucial bridging role in the innate and adaptive immune systems. In addition, it may be administered in combination with various drugs such as immunotherapy checkpoint inhibitors, as well as radiotherapy and chemotherapy, to produce highly synergistic effects.

CanWell’s TLR7 Agonist CAN1012 Received IND Approval by CDE in China

Canwell announced today that its TLR7 agonist CAN1012 had obtained clinical trial approval from China’s Center for Drug Evaluation (CDE). The approval allows CanWell to conduct Phase I clinical trials targeting advanced solid tumors in China. Prior to this, CAN1012 had obtained Phase I clinical trial approval from the US Food and Drug Administration (FDA) and Phase I clinical trial in the US is currently ongoing.

The CAN1012 Phase I clinical trial is an open-label, multicenter, dose-escalation, and dose-expansion study aimed at evaluating the safety, tolerability, and preliminary efficacy of the drug in late-stage solid tumor patients as a single agent, and determining the maximum tolerated dose and recommended Phase II dose. Currently, the study is being conducted simultaneously in China and the United States.

CAN1012 is a highly selective small-molecule TLR7 agonist developed by CanWell with global intellectual property rights. Preclinical studies have shown that it has high selectivity and potency, with low toxicities. It can exert sustained stimulation of the target cells in the tumor microenvironment, transforming “cold” tumors with low immune response into “hot” tumors with augmented immune response, playing a crucial bridging role in the innate and adaptive immune systems. In addition, it may be administered in combination with various drugs such as immunotherapy checkpoint inhibitors, as well as radiotherapy and chemotherapy, to produce highly synergistic effects.

CanWell’s TLR7 Agonist CAN1012 IND Granted Approval by US FDA

CanWell Pharma announced that its First-in-Class innovative drug, TLR7 agonist CAN1012, has been granted clinical approval by the US Food and Drug Administration (FDA) and will soon conduct Phase I clinical trials for various solid tumors.

CAN1012 is an innovative Toll-like receptor (TLR) 7 small molecule agonist independently developed by CanWell with global intellectual property rights. It is a sustained-release injection with high selectivity, high activity, and excellent physicochemical characteristics. Through sustained stimulation in the tumor microenvironment, CAN1012 can transform non-immune responsive “cold” tumors into immune responsive “hot” tumors, playing a crucial bridging role in both innate and adaptive immune systems, and enabling the body’s own immune system to recognize and attack tumor cells. In addition, it has a strong potential synergistic effect with various anti-cancer therapies, such as tumor immunotherapy checkpoint inhibitors. By locally releasing the drug, CAN1012 can effectively reduce adverse reactions caused by systemic immune system activation, making the drug safer and more effective.

Professor Qiang Pan-Hammarström Named Member of Scientific Advisory Board at CanWell

CanWell announced today that Professor Qiang Pan-Hammarström has joined the Scientific Advisory Board (SAB) at CanWell. Professor Pan-Hammarström is a leading researcher in studying the genetic mechanisms and treatment of primary immunodeficiency diseases, including B cell development, immunoglobulin gene diversity, the pathogenesis of B-cell lymphoma, and related immunotherapies. She is currently the Professor of Clinical Immunology at Karolinska Institute and the elected member of Nobel Assembly.

Professor Pan-Hammarström previously served as a visiting professor at Peking University, Sun Yat-sen University, and Rockefeller University in the United States, as well as a visiting scholar at Braeburn College and a visiting professor at Tianjin Medical University. She is currently a member of the scientific advisory committee of the KG Jebsen B-Cell Malignancy Research Center at the University of Oslo.  She also serves as an editor for Clinical Immunology, Frontiers in Immunology, and other journals, and has served as a committee member for the Swedish Research Council and the Swedish Cancer Society.

CanWell submits to US FDA the Investigational New Drug (IND) for its TLR7 agonist CAN1012 for Cancer Treatment

CanWell Pharma announced today that its independently developed First-in-Class innovative drug, TLR7 agonist, was submitted to the US Food and Drug Administration (FDA) for Investigational New Drug (IND) application and was accepted for review.

CAN1012 is an innovative Toll-like receptor (TLR) 7 small molecule agonist independently developed by CanWell with global intellectual property rights. It is a sustained-release injection with high selectivity, high activity, and excellent physicochemical characteristics. Through sustained stimulation in the tumor microenvironment, CAN1012 can transform non-immune responsive “cold” tumors into immune responsive “hot” tumors, playing a crucial bridging role in both innate and adaptive immune systems, and enabling the body’s own immune system to recognize and attack tumor cells. In addition, it has a strong potential synergistic effect with various anti-cancer therapies, such as tumor immunotherapy checkpoint inhibitors. By locally releasing the drug, CAN1012 can effectively reduce adverse reactions caused by systemic immune system activation, making the drug safer and more effective.